FDA 510(k) clearances — page 248
clearances on record, most recent first.
Clearances — page 248
24,701–24,800 of 176,542- K182075 — BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
- K182280 — ARK Tramadol Assay
- K182491 — Applanation tonometer AT-2
- K182506 — LipiScan Dynamic Meibomian Imager
- K182512 — Route 92 Medical Delivery Catheter
- K182584 — Lucent® XP
- K182724 — CelerityTM 10 STEAM Chemical Indicator
- K182810 — Distal Radius Plating System
- K182831 — SabreLine and SabreGuard Laser Fibers
- K183080 — Mega Plus Spine System
- K172897 — Neck Care Therapy, Model: SYK 509B
- K180175 — SignalMark Lung Biopsy Site Marker
- K180657 — Resin for Temporary Crown & Bridge
- K180670 — ICONN Campbell Interference Screw
- K180679 — CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
- K180754 — C-Zero Pedicle Screw System, Freedom Pedicle Screw System
- K180889 — Tractus Crossing Support Catheter
- K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
- K181695 — Nihon Kohden NKV-550 Series Ventilator System
- K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
- K182048 — Avenir Complete Hip System
- K182183 — GC70, GU60A, GU60A-65, GF50, GR50A; GR40CW; GM85; GC85A
- K182664 — FiXcision
- K182809 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K183100 — Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
- K183102 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
- K183111 — Contour 24
- K183212 — Nexus DR Digital X-ray Imaging System with stitching
- K183286 — 17HK701G-W
- K163601 — RII Smart IR Thermometer
- K173048 — No-contact Forehead Thermometer
- K173749 — AMRA Profiler
- K181107 — Elevo® Kit Snoring Intervention Device
- K181231 — DePuy Synthes T-PAL Spacer System
- K181357 — PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
- K181529 — Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
- K181727 — Vivid iq
- K181958 — MagnetOs Putty
- K182006 — Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
- K182016 — Simplicit90Y
- K182035 — FFRct
- K182125 — EVOLUTION Stemmed CS Femur
- K182373 — PowerLook Tomo Detection V2 Software
- K182438 — Synthetic Polyisoprene Lubricated Male Condom - 5 senses
- K182680 — KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
- K182926 — IntelliSpace Radiology
- K183040 — Zenition 70
- K183098 — Senhance Surgical System
- K183116 — Unity Network ID
- K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
- K180653 — Spartan eCoil System
- K181336 — HS50 / HS60 Diagnostic Ultrasound System
- K181825 — CAAS MR Solutions
- K181935 — Endoform Reconstructive Template - Non Absorbable
- K181970 — MectaLIF Posterior Extension
- K182076 — Elekta Unity
- K182479 — NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
- K182949 — Healix Compression Screw System
- K183034 — MOSAIQ Oncology Information System
- K183037 — Monaco RTP System
- K183065 — Coolrail Linear Pen
- K183069 — NobelZygoma 0°
- K183191 — 6420 Ultrasound System
- K173083 — IMPLANTER DENTAL PLANNING SOFTWARE
- K181159 — LZI Fentanyl Enzyme Immunoassay
- K181908 — Action Trackchair
- K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
- K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup
- DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
- K173495 — Single Use Hot Biopsy Forceps FD-231
- K173589 — Prizma
- K180298 — welloStationX
- K180388 — Transcend 365 miniCPAP System
- K180482 — ZOLL Propaq M
- K180495 — Tinnitus Sound Generator Module
- K180792 — Arterial Pressure Monitoring Set/Tray
- K180840 — UNO Negative Pressure Wound Therapy System
- K180918 — Planmed Verity
- K181221 — BD PhaSeal Optima Closed System Transfer Device
- K181286 — Ambu aScope RLS Slim
- K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
- K181588 — POPS! one Blood Glucose Monitoring System
- K181696 — ChitoZolve
- K181784 — Spectra S3 Plus
- K182046 — Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
- K182218 — FerriSmart Analysis System
- K182245 — EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
- K182249 — Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
- K182336 — SubtlePET
- K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
- K182498 — Advanced Skin Renewing Device
- K182600 — Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
- K182663 — Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
- K182797 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
- K182815 — XVWeb 3D
- K183023 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- K183030 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- K173701 — Implant-One System
- K180685 — AS-3XX Series Fingertip Pulse Oximeter
- K181427 — BD MAX Enteric Viral Panel, BD MAX Instrument
Data sourced from openFDA. This site is unofficial and independent of the FDA.